SOURCES SOUGHT
A -- Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT)
- Notice Date
- 5/15/2009
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-RDSS-HV-10-14
- Archive Date
- 6/14/2009
- Point of Contact
- Pam McCord-Reynolds, Phone: 301-435-0340, Joanne Deshler, Phone: (301) 435-0340
- E-Mail Address
-
mccordreynoldp@nhlbi.nih.gov, deshlerj@nhlbi.nih.gov
(mccordreynoldp@nhlbi.nih.gov, deshlerj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to this information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as a Data Coordinating Center (DCC) capable of conducting all aspects (administrative guidance, oversight, and support) of a multi-center Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) feasibility clinical study. Purpose and Objective The purpose of this clinical feasibility study is to explore the potential benefit of mechanical circulatory support therapy using ventricular assist devices (VADs) in functionally-impaired advanced heart failure patients who have not yet developed serious consequences from their disease. The study will serve to inform a pivotal trial directed at a large and growing patient population for whom VADs could offer substantial benefit beyond current medical therapies. Project Requirements The clinical study to be developed will test the hypothesis that VAD therapy improves both survival and quality of life in those advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. The recommendations made by the NHLBI Working Group on the Clinical Use of VADs are given below. • Study hypothesis: VAD therapy in the proposed patient population will improve functional status at 12 months post-randomization and all cause mortality will be no worse than that in the optimal medical management arm of the study. • Patients for the study should be ill enough to potentially experience both functional and survival benefits from the therapy without undue risk. • The estimated mortality rate for this group should be 20%- 30% at one year. • Patient Population Inclusion Criteria includes (1) hospitalization in past 6 months, (2) NYHA Class IV or Advanced Class III, (3) maximal evidence-based therapies for 3 months, (4) duration of heart failure of at least a year, and (5) no inotropic support for 30 days prior to enrollment. • The study should be randomized between VAD and optimal medical management (OMM) arms. • The primary endpoint should be a composite of survival and functional status where the improvement in functional status would need to be substantial and assessed through objective metrics. • Secondary endpoints are safety, secondary functional and physiologic markers, quality of life, neurocognition, and cost and cost effectiveness. • Patients should be followed for at least two years. • Substantial evidence of acceptable clinical performance is required for VADs to be used in the study. The DCC is expected to develop the clinical study plan (including specific inclusion/exclusion criteria and rationale, device(s) for the VAD therapy arm of the clinical study, adverse event definitions, and functional, quality of life, and neurocognitive measures), a draft protocol, negotiate and obtain signed contracts/agreements with clinical sites and industry partners. Required activities by the DCC include, but are not limited to, (1) finalizing all details of the clinical study to provide evidence for the proposed hypothesis and to assess recruitment and data quality; (2) finalizing the clinical protocol and protocol-related documents (e.g. informed consent form, case report forms, etc.); (3) implementation and conduct of the clinical study in accordance with all Federal requirements; (4) management and oversight of the conduct of the clinical study; (5) providing clinical research support services; (6) providing monitoring and safety oversight; (7) providing site training and support; (8) organizing investigator and DSMB meetings and teleconferences; (9) recruiting and randomizing patients; (10) organizing, conducting, and reimbursing for patient protocol evaluations and tests (including follow-up); and (11) analyzing the data and authoring and submitting papers on the study for publication. Anticipated Period of Performance The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement contract for a period of five years with an approximate award date of September 1, 2010. Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contract Specialist. The capabilities statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 10 single sided or 5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Pam McCord-Reynolds, Contract Specialist, at mccordreynoldp@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-RDSS-HV-10-14/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN01819849-W 20090517/090516161546-27d90800a132c8b57350ee96334a878b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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